drugset / Trial / NCT00325286

Open Label Study of Lithium Plus Extended-Release Carbamazepine (ERC-CBZ) for Rapid Cycling Bipolar Disorder

NCT00325286

Phase 4 Unknown 20 enrolled Creighton University Shire · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an open label design using Lithium plus extended release carbamazepine (Equetro) in combination for 6 months. Rapid cycling bipolar disorder is frequently treatment refractory and associated with repeated hospitalizations and complications. The results of this study will offer a promising approach to treat this complex disorder. The primary efficacy measure will be the time to relapse. Relapse will determined by the investigator based on the following: Need for additional pharmacotherapy for mood-related symptoms, hospitalization for an mood episode, increase of more than 50% in HAM-D and YMRS scores from the baseline visit.

Timeline

Start
2006-05
Primary completion
Completion
2008-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Carbamazepine Small molecule 1600 mg
Subject Lithium Unknown

Indications